Social PhobiaNCT01736631
Cognitive Behavioural Therapy for Social Phobia in People With Bipolar Disorder
A study testing Cognitive behavioural therapy (CBT) in people with Social Phobia and Bipolar Disorder, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
We are doing this study to find out how well cognitive behavioural therapy for social phobia works in people with bipolar disorder, who also have social phobia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Social Phobia, Bipolar Disorder
- What is being tested?
- Cognitive behavioural therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2013to 9 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of bipolar disorder I or II according to DSM-IV criteria and established in a structured interview
- Bipolar disorder in remission for at least 12 weeks; defined as absence of depressive or manic episode according to DSM-IV criteria established in a structured interview and confirmed by Montgomery-Åsberg Depression Rating Scale score ≤ 12 and Young Mania Rating Scale score ≤ 7
- Stable medication regime for at least 4 weeks prior to commencing CBT
- Current diagnosis of social phobia according to DSM-IV criteria and established in a structured interview, including duration of social phobia of at least 6 months irrespective of age.
- Social phobia is one of the primary complains (when bipolar disorder is in remission), justifying a therapeutic focus on this disorder.
- Ability and willingness to consent to treatment
- Ability to speak and write English
Who cannot join
- Current substance use disorder
- A previous adequate course of CBT for social phobia (at least 8 sessions) delivered by a trained therapist
- Currently receiving any psychological therapy
- Cognitive impairment that would preclude psychological therapy
- Actively suicidal
Trial locations and contacts
1 site in 1 country.
Canada1 site
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 2E2
About this study
Official title: Cognitive Behavioural Therapy for Social Phobia in People With Bipolar Disorder: A Pilot Study
We are doing this study to find out how well cognitive behavioural therapy for social phobia works in people with bipolar disorder, who also have social phobia.
Read the detailed description
Social phobia is a very prevalent anxiety disorder in people with bipolar disorder and is associated with adverse outcomes. Yet, social phobia is treatable by cognitive behavioural therapy or antidepressant medication. As antidepressants are often contra-indicated in people with bipolar disorder, cognitive behavioural therapy is the likely first choice treatment for social phobia in this population. However, people with bipolar disorder were excluded from previous clinical trials on treatment of social phobia. Our aim is to evaluate the acceptability and to provide a rough estimate of efficacy of cognitive behavioural therapy protocol for social phobia in people with bipolar disorder in a systematic case series. We will also prepare pilot data for evaluating the impact of treatment of comorbid social phobia on the long-term course of bipolar disorder.
- Conditions
- Social Phobia, Bipolar Disorder
- Being tested
- Cognitive behavioural therapy (CBT)
- Keywords
- social phobia, bipolar disorder, cognitive behavioural therapy
- Medical subject headings
- Phobia, Social, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioural therapy (CBT)Behavioural
The CBT intervention will follow the model of social phobia by Clark \& Wells (Clark \& Wells, 1995; Clark, 2005). The main elements of CBT for social phobia include reducing self-focus, dropping safety behaviours, and testing negative cognitions.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive behavioural therapy | Experimental | Cognitive behavioural therapy for social phobia in people with bipolar disorder Receives: Behavioral: Cognitive behavioural therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of cognitive behavioural therapy for comorbid social phobia in bipolar disorder
Acceptability of cognitive behavioural therapy for comorbid social phobia in bipolar disorder will be assessed as proportion of offered sessions attended
Measured: up to end of treatment (20 weeks)
Change on the Social Phobia Inventory (SPIN)
Measured: Baseline and end of treatment (20 weeks)
Secondary outcomes (4)
Change on the Liebowitz Social Anxiety Scale Scale Self-Report; Social Phobia Scale & Social Interaction Anxiety Scale; Social Phobia and Anxiety Inventory
Measured: Baseline and end of treatment (20 weeks)
Presence/absence of the social phobia diagnosis
Presence/absence of the social phobia diagnosis as established by Structured Clinical Interview for DSM Disorders
Measured: Baseline and end of treatment (20 weeks)
Depression symptom change
Depression symptom change as established by the Montgomery-Åsberg Depression Rating Scale and Beck Depression Inventory II
Measured: Baseline and end of treatment (20 weeks)
Mania symptom change
Change in symptoms of mania as established by the Young Mania Rating Scale
Measured: Baseline and end of treatment (20 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startMar 2013
- Primary completion24 Jan 2019
- Study completion9 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social PhobiaStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbara Pavlova, PhD DClinPsy, Principal investigator, Capital Health, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01736631
- Sponsor's protocol ID
- CBTSPBD-001
- Status last verified
- Jun 2017
- First submitted
- 27 Nov 2012
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioural Therapy for Social Phobia in People With Bipolar Disorder: A Pilot Study
- ClinicalTrials.gov ID
- NCT01736631
- Acronym / sponsor ID
- CBTSPBD-001
- Conditions
- Social Phobia, Bipolar Disorder
- Keywords
- social phobia, bipolar disorder, cognitive behavioural therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- Mar 2013 (actual)
- Primary completion
- 24 Jan 2019 (actual)
- Study completion
- 9 Sep 2022 (actual)
- First posted
- 29 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We are doing this study to find out how well cognitive behavioural therapy for social phobia works in people with bipolar disorder, who also have social phobia.
Detailed description
Social phobia is a very prevalent anxiety disorder in people with bipolar disorder and is associated with adverse outcomes. Yet, social phobia is treatable by cognitive behavioural therapy or antidepressant medication. As antidepressants are often contra-indicated in people with bipolar disorder, cognitive behavioural therapy is the likely first choice treatment for social phobia in this population. However, people with bipolar disorder were excluded from previous clinical trials on treatment of social phobia. Our aim is to evaluate the acceptability and to provide a rough estimate of efficacy of cognitive behavioural therapy protocol for social phobia in people with bipolar disorder in a systematic case series. We will also prepare pilot data for evaluating the impact of treatment of comorbid social phobia on the long-term course of bipolar disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavioural therapy | Experimental | Behavioral: Cognitive behavioural therapy (CBT)Cognitive behavioural therapy for social phobia in people with bipolar disorder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- A diagnosis of bipolar disorder I or II according to DSM-IV criteria and established in a structured interview
- Bipolar disorder in remission for at least 12 weeks; defined as absence of depressive or manic episode according to DSM-IV criteria established in a structured interview and confirmed by Montgomery-Åsberg Depression Rating Scale score ≤ 12 and Young Mania Rating Scale score ≤ 7
- Stable medication regime for at least 4 weeks prior to commencing CBT
- Current diagnosis of social phobia according to DSM-IV criteria and established in a structured interview, including duration of social phobia of at least 6 months irrespective of age.
- Social phobia is one of the primary complains (when bipolar disorder is in remission), justifying a therapeutic focus on this disorder.
Key exclusion criteria (5 listed)
- Current substance use disorder
- A previous adequate course of CBT for social phobia (at least 8 sessions) delivered by a trained therapist
- Currently receiving any psychological therapy
- Cognitive impairment that would preclude psychological therapy
- Actively suicidal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavioural therapy (CBT)The CBT intervention will follow the model of social phobia by Clark \& Wells (Clark \& Wells, 1995; Clark, 2005). The main elements of CBT for social phobia include reducing self-focus, dropping safety behaviours, and testing negative cognitions. | Behavioural | Cognitive behavioural therapy |
Primary outcome
Acceptability of cognitive behavioural therapy for comorbid social phobia in bipolar disorder
Time frame: up to end of treatment (20 weeks)
Acceptability of cognitive behavioural therapy for comorbid social phobia in bipolar disorder will be assessed as proportion of offered sessions attended
Change on the Social Phobia Inventory (SPIN)
Time frame: Baseline and end of treatment (20 weeks)
4 secondary outcomes
Change on the Liebowitz Social Anxiety Scale Scale Self-Report; Social Phobia Scale & Social Interaction Anxiety Scale; Social Phobia and Anxiety Inventory
Time frame: Baseline and end of treatment (20 weeks)
Presence/absence of the social phobia diagnosis
Time frame: Baseline and end of treatment (20 weeks)
Depression symptom change
Time frame: Baseline and end of treatment (20 weeks)
Mania symptom change
Time frame: Baseline and end of treatment (20 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Pavlova, PhD DClinPsy principal investigator
Capital Health, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioural therapy (CBT) in people with Social Phobia and Bipolar Disorder, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of cognitive behavioural therapy for comorbid social phobia in bipolar disorder (time frame: up to end of treatment (20 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.